主要工作职责（基本概况，主要功能，权限等）

The position is accountable for Quality Project Management and key responsible for process optimization, post market regulatory compliance. PMO will support key Quality projects aligned with business unit objectives and Quality strategies though the plenty of knowledge end to end Quality management and china regulatory & compliance requirement changes.

• The position is key point of contact for business units in developing Quality strategies and leading the projects of Quality process improvement.

• Engaged with business units and represents the project lifecycle portfolio to quality management which includes a cadence of obtaining project requests and leading cross-functional team to review the projects’ business case, conduct risk analysis and develop mitigation plan to be executed.

• Partner with Business Unit Regulatory, Marketing associates, Product Management, Financial and etc. for prioritization and execution strategies in local, regional and global wide.

• Represent Lifecycle Portfolio in Quality Management to appropriate governance bodies for approval of recommendations and ensure stakeholders understand outputs of all decisions and track project status.

• Be accountable for executing necessary changes based on China change control procedure and be responsible for leading collaboration for impact analysis, alignment on scope and changing Regulatory, Marketing associates, Product Management, Financial and etc. if applicable.

Other responsibilities defined in written procedures.

流程中规定的其它职责。

• This person is expected to follow all company compliance requirements including but not limit as safety policies & other safety precautions within work area, HCC, finance compliance and ensure multi-project coordination of changes for assigned business units.

• This role will also support related post market collaboration project with health authorities and universities and colleges.

• This role will provide leadership indirectly of cross-functional teams globally and across organizations.

基本任职资格（包括教育背景和/或知识和/或培训和/或相关工作经验）

• Minimum of a Bachelor’s Degree with a minimum of 5 years of experience in Operations, Engineering, NPD, Quality, Compliance, Regulatory and/or Manufacturing required. A Master’s Degree preferred

• Have a demonstrated track record of significant project management and leadership experience.

• The ability to lead a cross-functional team is required and experience leading cross-company and/or cross-region teams is preferred.

• Prior knowledge and understanding of the Medical Device or equivalent regulated industry, Quality Systems and Change Control procedures is preferred.

• Demonstrated Change and Stakeholder Management is required. Demonstrated understanding of compliance requirements for medical devices and labeling is preferred.

• Strong business and financial acumen is required.

• Demonstrated understanding of an end to end Quality.

• Prior knowledge and understanding of Manufacturing Packaging and Labeling processes is preferred.

• Advanced proficiency with written and verbal communications in English is required.

• Technical writing skills and experience are preferred. Proficiency with MS Office, Proficiency with Microsoft Projects and Proficiency with Statistical Analysis Software is preferred.
  

上班地址：漕河泾桂箐路新研大厦